Recombinant Zoster Vaccine: Early Safety Data from VAERS Assessed

RZV is preferentially recommended by the CDC's Advisory Committee on Immunization Practices (ACIP)

Early safety monitoring of the recombinant zoster vaccine (RZV) (Shingrix; GlaxoSmithKline) showed that serious adverse events were rare, and that findings were consistent with clinical trial data, according to a recent Morbidity and Mortality Weekly Report (MMWR).

After the approval of RZV for the prevention of herpes zoster in adults ≥50 years, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) began monitoring the vaccine in the Vaccine Adverse Event Reporting System (VAERS). Between October 20, 2017 and June 30, 2018, VAERS received 4381 reports on RZV (rate: 136 reports per 100,000 doses distributed), of which 3% (130) were considered serious. Pyrexia, injection site pain, and injection site erythema were the most commonly reported events, occurring in 23.6%, 22.5%, and 20.1% of cases, respectively.

Several reports also noted that healthcare providers made a decision not to administer a second dose of RZV after observing local or systemic reactions in patients. In the MMWR report, the CDC states that “In clinical trials, approximately 17% of RZV recipients experienced grade 3 reactions; these episodes were self-limited and resolved in a few days. Providers should expect such reactions in many of their patients and counsel them accordingly.”

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In addition, vaccination errors were identified in 230 reports with some reports detailing more than 1 error. Over half of the errors had to do with administration (62.2%), with incorrect route of administration being the most frequent cause (subcutaneous rather than the intramuscular route for which RZV is indicated).

Findings from 8 months of RZV surveillance indicate that initial vaccine safety data are reassuring. Regarding completion of the 2-dose series, the MMWR report states that “Counseling patients to expect self-limited adverse reactions such as pain, swelling and redness at the injection site, fever, chills, and body aches might ease concerns and encourage completion of the 2-dose RZV series.”